Aliskiren hemifumarate, having the chemical name: (2S,4S,5S,7S)—N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate [C30H53N3O6.0.5 C4H4O4] and the following structure:
is indicated for treatment of hypertension, acting as a renin inhibitor, and marketed by Novartis as TEKTURNA® in a once-daily formulation. Aliskiren and its related compounds are referred to in U.S. Pat. No. 5,559,111, while synthesis, pharmacological actions, pharmacokinetics and clinical studies of aliskiren and its related compounds are referred to in Lindsay, K. B. et al., J. Org. Chem., Vol. 71, pp 4766-4777 (2006) and in Drugs of the Future, Vol. 26, No. 12, pp 1139-1148 (2001).
US publication No. 2006/0154926 (US '926) describes the preparation of aliskiren hydrochloride. Preparation of aliskiren hemifumarate from aliskiren hydrochloride is also described in US '926.
WO2007/107317 describes the preparation of crystalline aliskiren hydrogen sulfate.
WO2007/098503 describes the preparation of crystalline aliskiren nitrate.
WO2008/055669 describes the preparation of crystalline aliskiren orotate.
The present invention discloses solid state forms of aliskiren compounds.